MONOLIFE: Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04775121

Collaborator

(none)

Enrollment

Location

Arm

24.6

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To measure the rate of bone marrow release and the lifespan of classical monocytes in the peripheral blood of patients with a chronic myelomonocytic leukemia

Condition or Disease	Intervention/Treatment	Phase
Myelomonocytic Leukemia	Other: Deuterium Glucose	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Deuterium glucose ingestion on a 3-hour period to label rapidly proliferating cells, followed by sequential collection of sorted classical monocytes on a 30-day periodDeuterium glucose ingestion on a 3-hour period to label rapidly proliferating cells, followed by sequential collection of sorted classical monocytes on a 30-day period

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Classical Monocyte Kinetics in Chronic Myelomonocytic Leukemia

Actual Study Start Date :

May 13, 2019

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Oral administration of 20 g Deuterium Glucose on a 3-hour period followed by sequential blood sampling to sort monocytes on a 30-days period of time	Other: Deuterium Glucose Oral administration of 20 g Deuterium Glucose on a 3-hour

Arm

Intervention/Treatment

Experimental: Experimental

Oral administration of 20 g Deuterium Glucose on a 3-hour period followed by sequential blood sampling to sort monocytes on a 30-days period of time

Other: Deuterium Glucose

Oral administration of 20 g Deuterium Glucose on a 3-hour

Outcome Measures

Primary Outcome Measures

Bone marrow release [up to 30 days]
To measure bone marrow release in the peripheral blood of patients with a chronic myelomonocytic leukemia and age-matched healthy volunteers

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria for patients with CMML:

Adult aged 18 years or over
CMML diagnosis according to the WHO 2016 criteria
Untreated patient or patient who did not receive a cytoreductive drug such as Hydroxyurea or an Erythropoiesis Stimulating Agent (ESA), or a growth factor, or Eltrombopag within the last 2 months or patient who did not receive a hypomethylating drug (Azacytidine or Decitabine) within the last 3 months
Affiliated to a social security system or beneficiary of the same
Able and willing (in the Investigator's opinion) to comply with all study requirements
Able to comprehend the Information Sheet and willing to give written informed consentent prior to any protocol-specific procedures performed
Willing to allow the Investigator to review data from the hospital medical records
For women of child-bearing age only, willingness to practice continuous effective contraception during the study. Women of childbearing potential must have a negative urine β-HCG pregnancy test within 15 days prior to the first administration of deuterium-labeled glucose. Sexually active male patients must agree to use condoms during the study. Also, it is recommended their women of childbearing potential partner use an effective method of contraception during the same period

Exclusion Criteria for patients with CMML:

Severe anemia (Hb < 10 g/dL)
Severe thrombocytopenia (Platelets < 50 G/L)
Transfusion dependency
Active or recent infection or febrile illness (<1 month)
Currently active inflammatory or autoimmune condition
Current systemic steroid therapy or other immunomodulatory drugs
Recent vaccination (< 1 month)
Recent surgery (< 1 month)
Active malignant disease
Renal disease (serum creatinine> 300umol/L)
Hepatic disease (transaminase levels >3x ULN)
Severe or unstable cardiovascular disease
Pregnancy or breastfeeding
Other current active medical condition which the Investigator considers a risk for entry in the study
Simultaneous participation in another concurrent research study that conflicts e.g. if it also involves blood sampling
Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Inclusion Criteria of age-matched healthy donors:

Volunteers aged 55 years or over
Able and willing to comply with all study requirements
Able to comprehend the Information Sheet and willing to give written informed consent prior to any protocol-specific procedures performed
For women of child-bearing age only, willingness to practice continuous effective contraception during the study. Women of childbearing potential must have a negative urine β-HCG pregnancy test within 15 days prior to the first administration of deuterium-labeled glucose. Sexually active male patients must agree to use condoms during the study. Also, it is recommended their women of childbearing potential partner use an effective method of contraception during the same period.

Exclusion Criteria of age-matched healthy donors:

Current treatment for any type of disease
Current active medical condition
Recent vaccination (< 1 month)
Recent surgery (< 1 month)
Pregnancy or breastfeeding
Simultaneous participation in another concurrent research study that conflicts e.g. if it also involves blood sampling
Subject under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gustave Roussy	Villejuif	Val De Marne	France	94800

Sponsors and Collaborators

Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gustave Roussy, Cancer Campus, Grand Paris

ClinicalTrials.gov Identifier:

NCT04775121

Other Study ID Numbers:

2018-A01882-53
2018/2774

First Posted:

Mar 1, 2021

Last Update Posted:

Mar 1, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myelomonocytic, Acute

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Study Results

No Results Posted as of Mar 1, 2021